Clinical trial · Interventional
Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed by PI final report submitted
Summary
Brief summary (as posted)
Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated vascularity through several mechanisms, including apoptosis (process of cell death) and anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the investigators' center, they have demonstrated that increased prostatic vascularity (blood vessels defined to prostate) detected ultrasonographically correlated with disease free survival after radical prostatectomy (surgical removal of entire prostate), and may be indicative of higher grade, higher stage disease. The significance of prostate neovascularity in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not been well studied. The investigators hypothesize that prostate cancer that recurs after radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may represent a minimally invasive marker of cancer stage, grade and response to treatment. The investigators propose a pilot study to assess the feasibility of serial enhanced transrectal ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced-Transrectal Ultrasound | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast Enhanced Transrectal Ultrasound (TRUS)
- interventionNames
- Drug: Contrast Enhanced-Transrectal Ultrasound
Primary outcomes (1)
- measure
- Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer
- timeFrame
- 1 year
- measure
- Patient Tolerance of TRUS Evaluation During/After Radiation Treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged 40 - 80 years old * Biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA \> 10. Pathology will be confirmed by at least two reviews * Patients opting for EBRT (external beam radiation therapy, standard of care) without hormonal ablation * Ability to undergo serial TRUS procedures * Ability to give informed consent Exclusion Criteria: * Subject has known hypersensitivity to octafluoropropane. * Evidence of distant metastatic disease on staging evaluation * Previous treatment for prostate cancer, including any form of androgen ablation * Previous procedures involving the anus or rectum, making serial TRUS difficult or dangerous * Expected life expectancy less than 10 years * Baseline testosterone \< 200 ng/dL * Subject with cardiac shunts and elevated pulmonary hypertension * Subject has worsening or clinically unstable congestive heart failure. * Subject has acute myocardial infarction or acute coronary syndrome. * Subject has ventricular arrhythmias or is high risk for arrhythmias. * Subject has respiratory failure, severe emphysema or pulmonary emboli. * Subject has a history of cardiac shunt or pulmonary hypertension.
References
Publications (4)
- BACKGROUNDHalpern EJ, Frauscher F, Strup SE, Nazarian LN, O'Kane P, Gomella LG. Prostate: high-frequency Doppler US imaging for cancer detection. Radiology. 2002 Oct;225(1):71-7. doi: 10.1148/radiol.2251011938. PMID 12354987
- BACKGROUNDHalpern EJ, Frauscher F, Rosenberg M, Gomella LG. Directed biopsy during contrast-enhanced sonography of the prostate. AJR Am J Roentgenol. 2002 Apr;178(4):915-9. doi: 10.2214/ajr.178.4.1780915. PMID 11906872
- BACKGROUNDNelson ED, Slotoroff CB, Gomella LG, Halpern EJ. Targeted biopsy of the prostate: the impact of color Doppler imaging and elastography on prostate cancer detection and Gleason score. Urology. 2007 Dec;70(6):1136-40. doi: 10.1016/j.urology.2007.07.067. PMID 18158034
- BACKGROUNDLinden RA, Halpern EJ. Advances in transrectal ultrasound imaging of the prostate. Semin Ultrasound CT MR. 2007 Aug;28(4):249-57. doi: 10.1053/j.sult.2007.05.002. PMID 17874649